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Recruiting NCT06541210

Building Community Living Labs in Black Communities to Advance Prostate Health Equity and Reduce Prostate Cancer Disparities in Black Men

No phase Interventional Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community Health Service, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Building Community Living Labs (CoLLab) in Black Communities With the Goal of Advancing Prostate Health Equity and Reducing Prostate Cancer Disparities in Black Men

Overview

This clinical trial the possibility of establishing a Community Living Labs (CoLLab) Learning Health System to facilitate access to prostate health Risk, Education, and Assessment in the Community with Help (REACH) services in Black men and compares the impact to American Legion Posts with no CoLLab set up at the individual and community levels. Cancer is the second leading cause of death for Black men and Black men are less likely to receive prostate cancer screening. CoLLab Learning Health System utilizes community health workers (CHW) that are well-trained to form a bridge between communities and clinicians. In fact, Black men who work with CHW's typically have better access to health services, gain knowledge about cancer, cancer prevention, treatment and may have better overall health outcomes. Establishing a CoLLab Learning Health System at American Legion Posts may improve access to clinical trials and prostate cancer services in Black men.

Detailed description

PRIMARY OBJECTIVES:

I. Co-create real-life user centric CoLLab Learning Health System at three American Legion Posts, compared to an American Legion Post with no CoLLab set-up. American Legion Post 197 will serve as the hub and Post 244 and Post 194 as the spokes.

II. Assess and evaluate the impact of the CoLLab Learning Health Systems compared to the comparison Post at the individual and community levels.

III. Explore the feasibility of replicating the CoLLab Learning Health System in Black communities nationally.

OUTLINE:

Participants access CoLLab Learning Health System to use any of the services at least twice monthly for up to 1 year.

Interventions

  • Other Community Health Service
    Access CoLLab Learning Health System to use any of the services
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Create real-life user centric CoLLab Learning Health System (program production) [Time frame: Up to 12 months]
  • Impact of the CoLLab Learning Health Systems [Time frame: Baseline; up to 12 months]
  • Feasibility of Replication - cost analysis [Time frame: Up to 24 months]
  • Feasibility of Replication - qualitative [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

  • AIMS 1 AND 3: Participants must be one of the following key personnel:
  • Community PI (n=1),
  • CoLLab Program Manager (n=1)
  • CoLLab Site Managers (n=3)
  • CoLLab CAB members (n=21)
  • 2 Community Health Workers (CHWs) per Post site (n=6)
  • AIMS 1 AND 3: Between the ages of 21 and 80.
  • AIMS 1 AND 3: Able to complete the survey in English.
  • AIMS 1 AND 3: Reside in the Jacksonville, FL and/or surrounding counties.
  • AIMS 1 AND 3: Willing and able to consent to the study.
  • AIM 2: Black adult of any gender.
  • AIM 2: Must be between the ages of 30 and 80.
  • AIM 2: Able to speak English.
  • AIM 2: Reside in the Jacksonville, FL and/or surrounding counties.
  • AIM 2: Willing and able to consent to the study.

Exclusion criteria

  • AIMS 1 AND 3: Younger than 21years or older than 80 years.
  • AIMS 1 AND 3: Not a resident of NE Florida. Unwilling or unable to consent to the study.
  • AIM 2: Younger than 30 years or older than 80 years.
  • AIM 2: Not a resident of NE Florida.
  • AIM 2: Unwilling or unable to consent to the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT06541210 · 23-007988 · W81XWH-22-PCRP-IDA · NCI-2024-06410 · CoLLab · 23-007988

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗